U.S. Reviews Health Effect of Implants
Health officials will not ban silicone gel implants for breast enlargement and other purposes for now, but say the materials’ packaging will be closely examined and federal experts will meet Nov. 22 to consider their potential risks.
The Public Citizen Health Research Group, a private health advocacy group, has urged the Food and Drug Administration to take swifter, more drastic measures against the materials.
The implants may cause cancer and the FDA should ban them immediately, Dr. Sidney M. Wolfe, who co-founded the health research group with Ralph Nader, said Wednesday.
Letter to the FDA
Citing internal documents his group obtained from the FDA and the implants’ major manufacturer, Dow Corning Corp., Wolfe made public a letter he sent to FDA Commissioner Frank Young.
Wolfe wrote Young that the FDA should ban the implants immediately, saying the documents his group obtained show that a Dow Corning study of the implants’ tumor-causing potential in rats has been the focus of an internal FDA debate for months.
He said FDA memos show some agency scientists considered the Dow Corning evidence alarming enough that they recommended months ago that the government issue a public warning and see that informational leaflets are sent to all “past, current and future patients.”
Although an ad hoc advisory group concluded that if there were a risk, it would be small, the FDA said last week that there are now sufficient concerns to order a new evaluation of the implants.
The FDA, which has said it will examine the materials’ packaging, has scheduled a Nov. 22 meeting of its plastic surgery devices advisory panel to “review potential health problems that may be caused by silicone breast implants.”
Increasing Concern
The agency said it “has been increasingly concerned about reports of adverse effects from breast implants, particularly in view of the large number of women who receive them.
“There have been reports of fibrous tissue growth around implants, which can cause a painful hardening of the breast,” the FDA said. “It is also possible that the implants could interfere with mammography pictures of the breast.”
Referring to the Dow Corning study showing the gel can produce tumors in laboratory rats, the FDA said: “Although it is unlikely that this finding is relevant to humans, the possibility of a cancer risk cannot be completely ruled out.”
The implants were on the market before enactment of the FDA’s 1976 medical device law and were “grandfathered” under the law. That means manufacturers will have until December 1990 to supply evidence that the implants are safe.
According to FDA estimates, about 2 million women have had silicone gel breast implants and about 130,000 more receive them each year. About 85% of the implants are for enlargement of healthy breasts and the others for breast reconstruction after mastectomy.
Each implant consists of a closed, breast-shaped bag filled with silicone gel. The bag is also made of silicone but in a solid form resembling heavy plastic sheeting. Solid silicone is used in many other kinds of implants and is not known to pose a risk. It is known that the gel form can slowly seep through the bag wall and migrate through the body.
Robert Grupp, a spokesman for Dow Corning, said his company “has confidence in the safety of appropriate uses of implants. . . . Patients who have had such surgery, or who are considering it, face no significant risk, based on all the data available to date.”
Grupp said Dow Corning knows of no evidence the implants have caused cancer in any women even though the devices have been widely used for many years.
